CA225103: A Phase II Study of a Combination of Cetuximab and Capecitabine in Patients With Metastatic Colorectal Cancer After Progression on Previous Fluoropyrimidine Containing Therapy
CA225103: A Phase II Study of a Combination of Cetuximab and Capecitabine in Patients With Metastatic Colorectal Cancer After Progression on Previous Fluoropyrimidine Containing Therapy
RATIONALE: Monoclonal antibodies such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine work in treating patients with metastatic colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood collection periodically for correlative studies. Samples are analyzed for expression of genes correlated with fluoropyrimidine responsiveness via quantitation RT-PCR; degree of expression of EGFR via immunohistochemistry; and expression pattern analysis via gene expression profiling and polymorphism.
After completion of study treatment, patients are followed periodically.
DISEASE CHARACTERISTICS:
Diagnosis of metastatic colorectal cancer
Measurable disease
Disease progression during prior fluoropyrimidine-containing therapy comprising irinotecan with or without oxaliplatin
Received standard first- and second-line irinotecan and oxaliplatin-based therapy
Patients who's disease progressed within 6 months of previous therapy are eligible
EGFR negative patients allowed
No untreated or uncontrolled brain metastasis
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Absolute neutrophil count ≥ 1,500/μL
Platelet count ≥ 100,000/μL
ALT ≤ 5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 5 times ULN
Serum creatinine ≤ 1.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No serious intercurrent infections or medical problems
No active or uncontrolled infections
No significant history of uncontrolled cardiac disease, including any of the following:
No prior severe infusion reaction to a monoclonal antibody
No known dihydropyrimidine dehydrogenase deficiency or evidence of past hypersensitivity to fluoropyrimidine
PRIOR CONCURRENT THERAPY: